Solos Endoscopy, Inc. Releases ISO 13485 Certification and CE Mark Schedule With Work to Begin May 29
BOSTON, MA--(Marketwire - May 23, 2012) -
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Solos Endoscopy, Inc. |
According to the schedule, Expert Resource will begin the project on May 29 and will immediately begin work with Solos Management on both Level 1 Documentation (Quality Manual) and Level 2 Documentation (Procedures). Expert Resources will provide comprehensive consulting, training and document preparation for Solos Endoscopy to create a quality management system that meets the requirements of the ISO 13485 standard.
Expert Resource will prepare Solos Endoscopy for the final audit, attend the final audit, and help interpret any findings. According to Expert Resource, their consultants maintain a 100% success rate of passing the final audit on the first attempt. Solos Endoscopy joins a high profile Expert Resource client list which includes BASF, Black & Decker, Dow Precision, Hitachi, J.D. Power & Associates, Microsoft Corporation, Northrop Grumman, Quest, and Toshiba, amongst many others.
Solos Endoscopy instruments are FDA approved. Upon Solos Endoscopy's receipt of its ISO 13485 Certification, the Company will be able to place the CE Mark on its entire instrument line. Both Solos and Expert Resource believe the ISO 13485 Certification and CE Mark initiative will be completed within the next 5 months. The Company will be posting its schedule on its website during the first week of June.
Expert Resource is an international consulting and training firm specializing in business improvement initiatives. ER helps medical device and medical laboratory companies implement ISO 13485, ISO 15189, ISO 14971, or GMP quality systems, obtain the CE Mark, submit FDA 510(k) applications, assist with clinical trials, and more. For more information on Expert Resource, visit www.expertresource.net.
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.